Biotechnology company Arcato Laboratories Inc announced on Wednesday successful topline results from its first-in-human Phase 1 study of ARC-001 Gel in patients following third molar (wisdom tooth) extraction surgery.

According to Arcato, ARC-001 Gel is a novel, proprietary, sustained release single-dose gel formulation combining three well characterised, non-addictive anaesthetics: Benzocaine, Lidocaine, and Bupivacaine. The novel formulation of ARC-001 Gel allows for a one-time local administration into the tooth socket following surgical extraction, with a pharmacokinetic profile supporting the potential for pain relief for up to seven days. ARC-001 Gel does not require an injection or a needle; the gel is easily administered directly into the extraction socket.

The Phase 1 primary endpoint of safety was achieved, supporting further Phase 2/3 development. Exploratory efficacy endpoints suggest pain reduction within the first 24 hours and that a single dose of ARC-001 Gel may provide pain relief for up to one week. Further exploratory analyses demonstrated that patients on placebo self-reported a need for opioids twice as often as those on ARC-001 Gel to manage pain.